Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery

Not Applicable

Completed

• Conditions: Laryngeal Mask Airway; Cataract Surgery; Ventilation
• Interventions: Procedure: Pressure Support Ventilation; Procedure: Unparalyzed Pressure Control Ventilation; Procedure: Paralyzed Pressure Control Ventilation; Device: Laryngeal Mask Airway; Drug: Sevoflurane

• Registration Number: NCT04241653
• Lead Sponsor: Sameh Fathy

Brief Summary

This study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post operative recovery. It is hypothesized that controlled ventilation without muscle relaxation will be advantageous to other modes in providing adequate surgical satisfaction with considerable depth of anesthesia and better recovery profile.

Detailed Description

Anesthetic management in pediatric cataract surgery constitutes a special challenge. Any eye movements can lead to an unsatisfactory surgical field and increase the risk of ophthalmological complications. Achieving adequate ventilation of children is considered another challenge due to huge variability in size and lung maturity. Spontaneous breathing is a popular mode of ventilation with several beneficial effects. Controlled ventilation without muscle relaxation using laryngeal mask airway is attractive option because the side effects of muscle relaxants are avoided. Therefore, this study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post-operative recovery. This prospective, randomized, comparative clinical study will include 150 children who will be scheduled for elective cataract surgery under general anesthesia in Mansoura ophthalmology center over one year. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality.The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to three equal groups according to computer-generated table of random numbers using the permuted block randomization method. In the first group, spontaneous ventilation will be maintained with pressure support; while in the two other groups, mechanical ventilation will be applied with pressure controlled modes. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.

Study Timeline

• Study Start: 2020-01-20
• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Primary Completion: 2021-01-10
• Study Completion: 2021-02-09
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• American Society of Anesthesiology (ASA) I and II patients.
• Scheduled for elective cataract surgery.

Exclusion Criteria

• Parental refusal of consent.
• Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology.
• Hyperactive airway disease or respiratory diseases.
• Children with developmental delays, mental or neurological disorders.
• Bleeding or coagulation diathesis.
• History of known sensitivity to the used anesthetics.
• Previous surgery in the same eye.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spontaneous Ventilation	Pressure Support Ventilation	Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Spontaneous Ventilation	Laryngeal Mask Airway	Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Unparalyzed Controlled Ventilation	Unparalyzed Pressure Control Ventilation	Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Unparalyzed Controlled Ventilation	Laryngeal Mask Airway	Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Paralyzed Controlled Ventilation	Paralyzed Pressure Control Ventilation	Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Paralyzed Controlled Ventilation	Laryngeal Mask Airway	Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Spontaneous Ventilation	Sevoflurane	Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Unparalyzed Controlled Ventilation	Sevoflurane	Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
Paralyzed Controlled Ventilation	Sevoflurane	Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.

Primary Outcome Measures

Name	Time	Method
Incidence of eye movements	Up to the end of the surgery	Incidence any upward or downward deviation of the vision axis during surgery will be recorded

Secondary Outcome Measures

Name	Time	Method
Changes in mean arterial blood pressure	Up to the end of the surgery	Blood pressure (mmHg) will be recorded at five-minute intervals until the end of the surgery
Improvement in postoperative emergence agitation scale	Up to 30 minutes after surgery	Agitation will be assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes. (1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)
Changes in heart rate	Up to the end of the surgery	Heart rate (beat/min) will be recorded at five-minute intervals until the end of the surgery
Changes in bispectral index	Up to the end of the surgery	Bispectral index values (0-100) will be recorded every five minutes until the end of the surgery
Amount of consumption of sevoflurane	Up to the end of the surgery	Sevoflurane consumption in milliliters will be measured and recorded
Changes in dynamic compliance	Up to the end of the surgery	Dynamic compliance (ml /cm H2O) will be recorded after stabilization of ventilation and at the end of surgery
Value of surgeon satisfaction from the procedure	After the end of the surgery	The ophthalmogist will be investigated postoperatively for the quality of surgical field (0-8; 0=None, 8=total satisfaction)
Changes in intraocular pressure	Up to the end of the surgery	Intraocular pressure will be measured (mmHg) in the non-operative eye using Schioetz-Tonometer

Trial Locations

Locations (1)

Department of Anesthesia, Mansoura University Hospitals; 🇪🇬 Mansoura, Dakahlia, Egypt